Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (the “Guidance”)……
By: Sheppard Mullin Richter & Hampton LLP